Table 1.
Baseline demographics and characteristics.
| Demographic/characteristic | Overall ITT population (n = 230) |
|
|---|---|---|
| Placebo (n = 56) | Inebilizumab (n = 174) | |
| Age | ||
| Mean (SD), years | 42.6 (13.9) | 43.0 (11.6) |
| Median (range) | 42.5 (18–74) | 43.0 (18–73) |
| Sex | ||
| Women | 50 (89.3) | 159 (91.4) |
| Racea | ||
| American Indian or Alaskan Native | 5 (8.9) | 14 (8.0) |
| Asian | 8 (14.3) | 39 (22.4) |
| Black or African American | 5 (8.9) | 15 (8.6) |
| White | 28 (50.0) | 92 (52.9) |
| Other | 10 (17.9) | 13 (7.5) |
| Multiple categories checked | 0 (0.0) | 1 (0.6) |
| Ethnicity | ||
| Hispanic or Latino | 15 (26.8) | 28 (16.1) |
| Disease duration, years | ||
| Mean (SD) | 2.77 (3.45) | 2.41 (3.30) |
| Median (range) | 1.38 (0.2–16.9) | 1.06 (0.1–22.2) |
| Type of most recent attack | ||
| Optic neuritis | 21 (37.5) | 85 (48.9) |
| Myelitis | 34 (60.7) | 99 (56.9) |
| Brain/brainstem | 10 (17.9) | 8 (4.6) |
| Prior treatment | ||
| Any therapyb | 55 (98.2) | 172 (98.9) |
| Plasmapheresis | 27 (48.2) | 67 (38.5) |
| Intravenous immunoglobulin | 3 (5.4) | 8 (4.6) |
| Any prior maintenance therapy | 38 (67.9) | 114 (65.5) |
| Corticosteroids | 23 (41.1) | 79 (45.4) |
| Non-biologic immunosuppressionc | 26 (46.4) | 79 (45.4) |
| Azathioprine | 22 (39.3) | 63 (36.2) |
| Mycophenolate mofetil | 7 (12.5) | 26 (14.9) |
| Methotrexate | 0 (0.0) | 2 (1.1) |
| Biologic agent | 5 (8.9) | 25 (14.4) |
| Rituximab | 4 (7.1) | 13 (7.5) |
| Interferon beta | 1 (1.8) | 7 (4.0) |
| Natalizumab | 0 (0.0) | 2 (1.1) |
| Glatiramer acetate | 0 (0.0) | 2 (1.1) |
| No prior maintenance therapy | 18 (32.1) | 60 (34.5) |
| Baseline Gd-enhancing lesions | ||
| Mean (SD) | 0.9 (0.9) | 1.2 (1.2) |
| Median (range) | 1.0 (0.0–4.0) | 1.0 (0.0–5.0) |
| Baseline EDSS score | ||
| Mean (SD) | 4.19 (1.68) | 3.81 (1.81) |
| Median (range) | 4.0 (1.0–8.0) | 3.5 (0.0–8.0) |
EDSS = Expanded Disability Status Scale, Gd = gadolinium, ITT = intention-to-treat, SD = standard deviation.
Data are n (%) unless stated otherwise.
a
Race was self-reported by patients; ‘Other’ included Mestizo (n = 12), Mixed (n = 6), Arab, Hispanic, Vietnamese, Caucasian/Latino, and New Zealand Maori (all n = 1).
b
Includes any prior treatment for neuromyelitis optica spectrum disorder, including rescue and maintenance therapy; some patients received more than one maintenance therapy.
c
All other non-biologic, non-corticosteroid treatments including azathioprine, cetirizine, cyclophosphamide, cyclosporine, fingolimod, methotrexate, mitoxantrone, mizoribine, mycophenolate mofetil, or pentoxifylline.